VaxArray® Pandemic Influenza Hemagglutinin (HA) Potency Test
Rapid Quantification of HA in H5, H7, H9 Vaccines
The VaxArray Influenza Pandemic Hemagglutinin Potency test is a simple multiplexed sandwich immunoassay that accurately quantifies HA protein from the most recent pre-pandemic and zoonotic influenza viruses. Subtype specific antibodies for A(H5), A(H7), and A(H9) influenza strains can quantify HA through all stages of vaccine manufacturing, including in low-dose adjuvanted formulations.
The VaxArray® Influenza Pandemic HA Potency Test Kit contains 32 microarrays and most of the reagents needed to quantify H5, H7, and H9 HA in crude samples or final vaccine formulations. The test is a based on a multiplexed immunoassay in which a panel of monoclonal antibodies is used to capture subtype-specific antigen. Readout is based on fluorescence from an antigen-specific antibody that is conjugated with a proprietary fluorophore. The arrangement of monoclonal capture antibodies within each microarray (i.e., within each well) is shown in the figure below.
Assay features include:
- Equivalence to SRID. When calibrated appropriately VaxArray exhibits equivalence to SRID for monovalent and multivalent vaccines. VaxArray enables rapid quantification of hemagglutinin throughout the manufacturing process without changing methods along the way.
- Subtype Specific and Multiplexed. Quantify monovalent or all components of a quadrivalent formulation. The microarray utilizes multiple antibodies for each subtype with 9 replicates per antibody in a single test. This provides high confidence in results for protein quantification.
- Stability Indicating. As an immunoassay, VaxArray Influenza measures biologically relevant forms of HA.
- Compatibility with Adjuvants. HA quantification is unaffected by the presence of adjuvant at dose-sparing concentrations.
- Off the Shelf Kit. Eliminates need for in-house preparation of plates or gels; streamlines testing (time to result is less than 2hrs) and can be used with or without standardized reagents.
- Fast & High Throughput. With a turn-around time of <2 hours, a single analyst can easily quantify 48 samples in a half day.
- Automated Image and Data Processing. Software developed with FDA 21 CFR Part 11 + EU Annex 11 compatible features reduces time spent processing data, enables straightforward data integrity compliance, and maintains digital records with audit log traceability.
Please refer to the Literature tab for links to scientific publications as well as application and technical notes.
VaxArray users must select and order the appropriate fluor-tagged label antibody from the range offered by InDevR (see below for the anti-HA mAb list). In general, for egg-propagated flu vaccines we recommend the nearly universal polyclonal antibody (VXI-7601) for ease of use and broad applicability. For cell-propagated flu vaccines, recombinant proteins, or virus-like particles, it is recommend that you review the Label Selection Guide or, better yet, speak with our scientists about which label antibodies to try. It is sometimes necessary to experimentally evaluate a panel of label antibodies in order to optimize sensitivity.
Conjugated Antibodies Available as Labels for HA:
A&B pAb Label (10X) - P/N: VXI-7601
A H7-05 mAb Label (10X) – P/N: VXI-7605
Not sure what label to choose? Label Selection Guide
Assay (exact metrics are strain specific):
- Time to result ≤ 2 hours
- Precision ≤ 10% CV
- Limit of detection < 10 ng/mL
- Linear dynamic range ≥ 100
- Stability indicating - yes
The VaxArray Pandemic HA kit is manufactured under cGMP conditions within ISO 13485:2003 certified facilities.
- Microarray imaging system with internal computer
- Operating system – Windows 7
- Spatial resolution - 6.7 μm
- Signal resolution - 16 bit
- Camera pixel resolution - 964 x 960
- Electrical supply - 100-240V, 50/60 Hz
- Dimensions, length x width x height - 17.25" x 13.5" x 10"
- Weight – 32.8 pounds
- Operating environment +15°C to +35°C 10% to 75% humidity (non-condensing)
- Storage temperature - +5°C to +40°C
- Shipping temperature - +5°C to +40°C
The VaxArray Microarray Imaging System was tested to conform with all CE standards, including the IEC 61010-1 (Ed. 2.0). Refer to the literature tab for the Declaration of Conformity.
- A neuraminidase potency assay for quantitative assessment of neuraminidase in influenza vaccines
- VaxArray for hemagglutinin and neuraminidase potency testing of inﬂuenza vaccines
- VaxArray potency assay for rapid assessment of pandemic influenza vaccines
- VaxArray assessment of influenza split vaccine potency and stability
- Titer on Chip: New Analytical Tool for Influenza Vaccine Potency Determination
- VaxArray Seasonal 2017 World Vaccines Poster
- VaxArray Seasonal 2017 ESACT Poster
- VaxArray Seasonal 2016 Options Poster
- VaxArray Calculations and Analysis
- VaxArray Accuracy and Precision
- VaxArray Best Practices for Accuracy
- VaxArray Imaging System Declaration of Conformity
- VaxArray Influenza Comparison Chart
- VaxArray HA Comparison to SRID
- VaxArray Pandemic Hemagglutinin Product Sheet
- Operation Manual for VaxArray Influenza Potency Assays
- VaxArray Imaging and Analysis System Operation Manual
- Reference Guide for VaxArray Influenza Assays
Safety Data Sheets (SDS)
Q1) Are the antibodies of the VaxArray Influenza Seasonal Hemagglutinin Potency Test Kit sufficiently broadly reactive to detect the targeted HA in the event of antigenic drift?
A1) Yes. The VaxArray Influenza Seasonal Hemagglutinin Potency Test Kit’s panel of antibodies have demonstrated broad coverage of historical vaccines dating back over 15 years. However, because future antigenic drift is difficult to predict, InDevR has developed a process for evaluating assay performance against novel influenza strains.
Q2) Can VaxArray be used with crude and in-process samples?
A2: Yes. Low limits of detection and high sensitivity allow quantification even in difficult matrices.
Q3) Can VaxArray be used to quantify HA from live, active virus?
A3) Yes. Active or inactive viral material is able to be quantified using VaxArray.
Q4) Is VaxArray stability indicating?
A4) Yes. By using conformational epitopes for antigens of interest, VaxArray is able to quantify the biologically relevant forms of antigenic proteins.
Q5)What types of vaccine does VaxArray work with?
A5) Many types of vaccine can be characterized using VaxArray. Split, live-attenuated, recombinant, whole virion and others can be easily quantified for antigenic protein content.
Q6) Can I use an internal standard for VaxArray?
A6) Yes. Internal standards work very well in our assay as inactivation conditions are usually well matched between internal standards and sample.
Q7) How do I gather and analyze the data from the slide after processing?
A7) InDevR has developed a VaxArray specific software package that is installed on the VaxArray Imaging System. This intuitive software package will walk you through the set-up, imaging, and analysis of data. Results are presented in easy to understand reports.
Q8) Is the VaxArray Software 21 CFR Part 11 compatible?
A8) Yes, digital signatures, user permissions and audit reports allow compatibility with 21 CFR Part 11 requirements.
Q9) How can I know that the VaxArray assay is appropriate for my samples?
A9) The VaxArray science team is here for you! Our team of expert scientists will discuss your sample and analysis needs with you to determine the best course of action. Custom development is available for samples that do not fit our current VaxArray Assay Kit offerings.
Q10) Is VaxArray only for influenza vaccines?
A10) InDevR is working to expand the applications of VaxArray technology to other vaccines. Talk to our Sales Representatives about custom development specific for your needs.